替卡格雷基因毒杂质！？Impurities UL127, UL133 and UL134 (also an important metabolite) are above the qualification level of 0.15% but non-genotoxic. Although the Applicant did not perform the animal qualification study with the recommended amount in line with the proposed specification or higher of impurities UL127 and UL133 respectively, the Applicant showed by extensive comparison of studies with different amounts of these impurities that it is highly unlikely that especially UL127 but also UL133 at the proposed limits in the product pose a significant risk for toxicity in humans. Several of impurities have been tested for genotoxicity and found negative. The impurities AZ13232761 and C3RO were found positive and the applicant stated that these impurities are kept below the threshold of toxicological concern查看更多
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